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The boom of biological medicines

The cold chain is becoming a major issue in the pharmacy sector, particularly
in the transportation of
medicines stage. The biomedicine market is currently booming.

Biological medicines: what
are they?

Stemming
from biotechnologies, biological medicines are also called biomedicines or biotherapies.
They are generally produced from living cells using recombinant DNA
technologies, or genetically modified cells. These techniques help to develop
vaccinations, hormones, transformed viruses, modified cells or plants. Biomedicines
help to treat serious illnesses: cancers, autoimmune diseases, diabetes, etc.

These
medicines are affected by the challenges
of the cold chain.
Out of the world’s 10 best-selling pharmaceutical products in 2014, 5 medicines
must be stored at a specific temperature range (4 between +2°C and +8°C, 1 between
+15°C and +25°C) and these concern biomedicines.

Top
10 of the world’s best-selling medicines in 2014 (source: IMS Health)

Recent healthcare innovations
depend largely on the development of biological medicines

Today, 80% of new molecules on the market stem
from biotechnologies. In 2005, they only represented 20 to 30% of the
market, according to the report “The place of biotechnologies in France and
Europe” by the MP Jean-Yves Le Déaut, President of OPECST (Parliamentary Office
for Evaluation of Scientific and Technological Options).

In 2014,
out of the world’s 20 best-selling pharmaceutical products, 11 were biological
medicines, according to IMS Health - which also predicted an increase in the biomedicine market. It is
estimated to reach 250 billion dollars by 2020.

Top 20 of
the world’s best-selling pharmaceutical products in 2014

In order to
develop new treatments, pharmaceutical companies are turning towards open
innovation and are calling on cutting-edge start-ups capable of developing precision medicines. Oncology, for
example, will be a key area for orphan medicines, 40% of which stem from
biotechnologies. These therapeutic approaches make up one of the foundations of
the concept of personalised medicine.

Biosimilars: a market
opportunity

Some patents for biological medicines will come into
the public domain over the next 5 years. In concrete terms, 9 biomedicines which
themselves alone generate 40% of the current global market for biological
medicines will soon see (or have recently seen) their patent expire.This paves the way for the marketing of biosimilars and
is a very attractive opportunity for manufacturers (this market will represent
between 11 and 25 billion dollars in 2020). Pharmaceutical laboratories are
already developing biosimilars – modelled on generic medicines, alternatives to
chemical medicines.

Moreover, health
organisations are exerting pressure to control healthcare spending: the cost of
a biological medicine is higher than that of other medicines. A biosimilar
medicine is on average 20 to 30% cheaper
than a reference biological medicine and would therefore make savings.

Lastly, biosimilars
would allow developing countries easier
access to adapted treatments, particularly for conditions which require excessively
costly and inaccessible care for patients who do not benefit from social
security.

The cold chain more topical
than ever

With the
development of biological medicines and biosimilars, compliance with the cold chain is going to
become a recurring theme in the years to come.

Everybody
involved in healthcare is affected by the storage of these medicines: pharmaceutical
companies, logisticians, distributors, clinics and hospitals, pharmacies, and
of course the patients. Everyone must be aware of the appropriate actions and
good practices they must follow to ensure the effectiveness of the treatments.